{
  "FullStudy":{
    "Rank":218002,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514032",
          "OrgStudyIdInfo":{
            "OrgStudyId":"TOP-Stone"
          },
          "Organization":{
            "OrgFullName":"University of Zurich",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones",
          "OfficialTitle":"TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2014",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2014",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 19, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 20, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Zurich",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.\n\nTrial with surgical intervention"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Kidney Stones"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"230",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Extracorporal shockwave lithotripsy",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Extracorporal shockwave lithotripsy"
                  ]
                }
              },{
                "ArmGroupLabel":"Retrograde intrarenal surgery",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Retrograde intrarenal surgery"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Extracorporal shockwave lithotripsy",
                "InterventionDescription":"Extracorporal shockwave lithotripsy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Extracorporal shockwave lithotripsy"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"Retrograde intrarenal surgery",
                "InterventionDescription":"Retrograde intrarenal surgery",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Retrograde intrarenal surgery"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"stonefree-rates 3month after therapy",
                "PrimaryOutcomeTimeFrame":"3 month"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size)\n\nmale and female patients between 18 and 99 years\ninformed consent signed by patient after explanation of the both treatment-modalities\n\nExclusion criteria: - age < 18 or > 99\n\npregnancy\nbreastfeeding mother\ndisorders of blood clotting\nkidneystones > 15mm\naneurysms of the aorta or renal artery\nsevere skeletal deformations which hamper one of the treatment modalities\nsynchronous stones of the ipsilateral ureter\nstones which can not visualized which X-ray or sonography",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Damian Weber, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+41 44 2555407",
                "CentralContactEMail":"damian.weber@usz.ch"
              },{
                "CentralContactName":"Michael Muentener, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+41 44 2555403",
                "CentralContactEMail":"michael.muentener@usz.ch"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"01 Studienregister MasterAdmins",
                "OverallOfficialAffiliation":"UniversitaetsSpital Zuerich",
                "OverallOfficialRole":"Study Director"
              },{
                "OverallOfficialName":"Michael Muentener, MD",
                "OverallOfficialAffiliation":"University Hospital Zurich, Division of urology",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University Hospital Zurich, Urology",
                "LocationStatus":"Recruiting",
                "LocationCity":"Zurich",
                "LocationCountry":"Switzerland"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007669",
                "ConditionMeshTerm":"Kidney Calculi"
              },{
                "ConditionMeshId":"D000053040",
                "ConditionMeshTerm":"Nephrolithiasis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000002137",
                "ConditionAncestorTerm":"Calculi"
              },{
                "ConditionAncestorId":"D000020763",
                "ConditionAncestorTerm":"Pathological Conditions, Anatomical"
              },{
                "ConditionAncestorId":"D000007674",
                "ConditionAncestorTerm":"Kidney Diseases"
              },{
                "ConditionAncestorId":"D000014570",
                "ConditionAncestorTerm":"Urologic Diseases"
              },{
                "ConditionAncestorId":"D000052878",
                "ConditionAncestorTerm":"Urolithiasis"
              },{
                "ConditionAncestorId":"D000014545",
                "ConditionAncestorTerm":"Urinary Calculi"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M25713",
                "ConditionBrowseLeafName":"Nephrolithiasis",
                "ConditionBrowseLeafAsFound":"Kidney Stones",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9276",
                "ConditionBrowseLeafName":"Kidney Calculi",
                "ConditionBrowseLeafAsFound":"Kidney Stones",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3981",
                "ConditionBrowseLeafName":"Calculi",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21103",
                "ConditionBrowseLeafName":"Pathological Conditions, Anatomical",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9281",
                "ConditionBrowseLeafName":"Kidney Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15902",
                "ConditionBrowseLeafName":"Urologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M25690",
                "ConditionBrowseLeafName":"Urolithiasis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15878",
                "ConditionBrowseLeafName":"Urinary Calculi",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}